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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05954520
Other study ID # 18675
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date May 30, 2025

Study information

Verified date May 2024
Source Indiana University
Contact Jennifer Lentz, PhD
Phone 18128558945
Email jjlentz@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception.


Description:

In this study, we are interested in how nonlinear algorithms influence speech perception. Nonlinear algorithms are used within hearing aids and personal sound amplifiers to provide comfort to the listener. One of these algorithms provides amplification (gain) in a manner that depends on the level of the input sound.: Low-level sounds are amplified much more than high-level sounds. This type of amplification makes sounds more comfortable for listeners, but also distorts incoming sounds. To determine the effect of these algorithms on speech understanding, we will evaluate the following factors on speech perception, within the context of these algorithms: - The input Signal-to-Noise ratio (SNR) to the algorithm (3 different SNRs) - The type of background noise (20 people talking or 2 people talking) - Algorithm settings (slow and fast - whether changes to gain applied to fluctuating input sounds occurs quickly or slowly) To address our questions, we are using a wearable processor (Tympan) that allows for real-time processing of audio signals. The Tympan itself contains microphones, a processor, and small earpieces that include speakers. A listener can wear the earpieces, like headphones, and listen to sounds processed by the Tympan in real time. The Tympan allows us access to the algorithms and to the sounds processed by the algorithms so that we cannot algorithm behavior to speech perception. Our study will complement existing work on speech perception and nonlinear algorithms, but our study will be the first to use a wearable processor in which the specific algorithm is known, tailored to an individual's hearing levels, and which allows for direct calculation of the output SNR. Most studies also have not measured speech perception, and this will be one of only a handful of studies with that objective.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 30, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Between the ages of 18 and 65 - Native speaker of English - Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below. Exclusion Criteria: - Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss. - Subjects who younger than 18 or older than 65. - Subjects who are not native speakers of English. - Subjects with thresholds more than 70 dB HL at 2000 Hz and below

Study Design


Intervention

Device:
Tympan
Participants will wear a prototype hearing aid (called the Tympan)

Locations

Country Name City State
United States Health Sciences Building Bloomington Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech understanding Percent words correct will be measured 1-2 hours
Secondary Preference Algorithm preference will be measured for each experimental condition 15 minutes
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